THE Food and Drug Administration (FDA) encourages importers to avail themselves of the Bayanihan One Stop Shop (BOSS) facility to fast-track importation of critical Covid-19 commodities intended for commercial distribution.
Dr. Oscar G. Gutierrez Jr., officer in charge director of the FDA’s Policy and Planning Service, said in a recent e-forum that an online one-stop shop for securing the license to operate (LTO) to import Covid-19 critical commodities for commercial distribution is already available.
The BOSS was created under Joint Memorandum Circular (JMC) 1, Series of 2020 issued April 2, 2020. Critical Covid-19 health products include sanitizers/hygiene products (alcohol); personal protection equipment; diagnostic products like the PCR and Antibody/Rapid Test Kit; case management products such as medicines, medical devices, respirators and ventilators; and food products like processed foods, food supplements and raw materials.
The BOSS is a single window for online applications for importation of Covid-19 critical commodities for commercial distribution, designed to further streamline and facilitate the procedure for securing the LTO and importing these critical goods.
Its implementation involves the FDA, the Bureau of Customs (BOC), and the Anti-Red Tape Authority (ARTA), according to Gutierrez. Under normal conditions, importations of Covid-19 critical commodities regulated by the FDA will require the issuance of the relevant LTO to the importer and registration or notification of every health product unless explicitly exempted.
The importer will then be required to present this LTO and/or the Certificate of Product Registration (CPR)/Notification to the BOC for the latter to clear the commodities for entry into the country.
This builds bottlenecks and challenges to the importation process, necessitating the creation of BOSS under Republic Act 11469, or the “Bayanihan to Heal as One Act.” Through this application facility for LTO, the FDA will be performing a three-step procedure—from submission and evaluation to payment—all done online, said Gutierrez. The LTO “can be processed within the day, or even a matter of hours, while printing of the LTO will be done by the applicants at the convenience of their homes and offices,” he added.
In addition, he said, BOC can already view what is happening at the FDA so the bureau can start processing the release of the products.
The FDA BOSS application portal may be accessed at https://boss.fda.gov.ph. Gutierrez said that as of May 19, 2020, FDA received 205 applications for LTOs and approved 90. Reasons for denial included misdeclaration of company name or company owner, typo errors, and incorrect document for business name registration.